Evidence map›Paper›PMID 35387488›Full record

ArticleHuman gene therapy2022

Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification.

James Z Deng, Richard R Rustandi, Damon Barbacci, Andrew R Swartz, Amanda Gulasarian, John W Loughney

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Human gene therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04152863 phase2terminatednot on this map

A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2023Enrolled85ConditionsAdvanced/Metastatic MelanomaArmsGebasaxturev IV, Gebasaxturev ITu, Pembrolizumab
NCT04521621 phase1 / phase2terminatednot on this map

A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2023Enrolled76ConditionsNeoplasm MetastasisArmsGebasaxturev, Pembrolizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

James Z DengVaccine Analytical Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.ORCID 0000-0002-6599-7716
Richard R RustandiVaccine Analytical Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Damon BarbacciVaccine Analytical Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Andrew R SwartzVaccine Process Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Amanda GulasarianVaccine Process Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
John W LoughneyVaccine Analytical Research & Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oncolytic virus immunotherapy is emerging as a novel therapeutic approach for cancer treatment. Immunotherapy clinical drug candidate V937 is currently in phase I/II clinical trials and consists of a proprietary formulation of Coxsackievirus A21 (CVA21), which specifically infects and lyses cells with overexpressed ICAM-1 receptors in a range of tumors. Mature Coxsackievirus virions, consisting of four structural virion proteins, (VPs) VP1, VP2, VP3, and VP4, and the RNA genome, are the only viral particles capable of being infectious. In addition to mature virions, empty procapsids with VPs, VP0, VP1, and VP3, and other virus particles are produced in V937 production cell culture. Viral protein VP0 is cleaved into VP2 and VP4 after RNA genome encapsidation to form mature virions. Clearance of viral particles containing VP0, and quantification of viral protein distribution are important in V937 downstream processing. Existing analytical methods for the characterization of viral proteins and particles may lack sensitivity or are low throughput. We developed a sensitive and robust reverse-phase ultra-performance chromatography method to separate, identify, and quantify all five CVA21 VPs. Quantification of virus capsid concentration and empty/full capsid ratio was achieved with good linearity, accuracy, and precision. ClinicalTrials.gov ID: NCT04521621 and NCT04152863.

Indexed as

CapsidOncolytic VirusesCapsid ProteinsChromatographyRNA, ViralViral ProteinsCapsid ProteinsRNA, ViralViral Proteinscapsid empty/full ratiocapsid quantificationLC/MSoncolytic CoxsackievirusRP-UPLCtherapeutic viral vectorV937virion protein analysis

Identifiers

PMID35387488
PMCPMC9347376
OpenAlexW4224306706

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.